Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Nextkidney S.A.
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis.
Detailed Description
This clinical trial is being conducted to evaluate the biochemical safety of dialysate regeneration with the PAK HD sorbent cartridge in a limited number of patients and treatments. Therapy efficacy of the PAK HD sorbent therapy will be compared to conventional hemodialysis under the same therapy settings. The trial will use only one single PAK HD sorbent therapy per patient, and a total of 3 patients. The PAK HD therapies will be performed in the middle of the week.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be adults \>/= 21 years old and \<80 years old.
- •Subjects must be weighing \>/= 55kg and \<90kg (patient's dry weight).
- •Subjects must have stable haemoglobin \>/= 10.5g/dL, 2 months prior to enrolment
- •Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment:
- •Patient allowable serum biochemistry ranges Allowable pre-dialysis serum values Na \>/= 132 mmol/L or \</= 145mmol/L HCO3 \>/= 15mmol/L or \</= 30mmol/L K \>/= 3.5mmol/L or \</= 5.8mmol/L
- •Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as:
- •Haemodynamic stability during dialysis (absence of hypotensive events and symptomatic arrhythmias), no angina pectoris, AND
- •No altered level of consciousness during dialysis.
- •Subjects with a well-functioning vascular access (native fistula graft):
- •capable of providing a blood flow rate of \>/= 250 mL/min, AND
Exclusion Criteria
- •Subjects with haemoglobin level of \<10.5g/dL in any measurement 2 months prior to enrolment.
- •Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
- •sodium concentration \<132 mmol/L or \> 145mmol/L
- •bicarbonate \<15mmol/L or \>30mmol/L
- •plasma potassium concentration \<3.5mmol/L or \>5.8mmol/L
- •urea \<15mmol/L or \>28 mmol/L
- •Subjects with severe hypertension: systolic blood pressure \> /=180 mmHg, diastolic blood pressure \>/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
- •Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
- •Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.
- •Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
Outcomes
Primary Outcomes
The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
Time Frame: 2 weeks
The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints: 1. Absence of serious adverse events (SAE) 2. Absence of critical change in patient's clinical condition and vital parameters (Blood pressure, heart rate, body temperature and respiratory rate and pulse oximetry) during treatment. 3. Absence of critical change in haematology and biochemistry immediately before the start of therapy and immediately after completion of therapy, including acid-base state, electrolytes, and ammonia.
Secondary Outcomes
- The secondary objective of this study is to evaluate the efficacy of the PAK HD therapy in comparison to CHD, in terms of uremic toxin removal efficacy (urea, creatinine and phosphate).(2 weeks)